Saturday, February 9, 2013

You were awarded a K99/R00 Transition to Independence award from the National Institutes of Health (NIH) and you even have a tenure-track job lined up!! You have survived writing your K99 and you think you got this whole NIH thing down. Think again...

The K99/R00 is an wonderful initiative that helps young investigators in training to complete their postdocs and transition to an independent position with almost as much money as a second start-up. You are NIH funded which increases your chances of getting a job in the first place, but the NIH never makes up codes in vain and the name K99/R00 means that you actually have to apply for the R00 portion.

If you have done your homework, you have talked to your Program Official at the NIH throughout your job negotiation process and have had them review and approve the terms of your job offer. In fact, they have helped you define what those terms should be so that they comply with the rules and regulations attached to your NIH funding, in the sense that no institution can shortchange you because you already have a K99. I have a lag of almost a year between signing an offer and starting my job, but 6 months before my move, my PO already had me thinking about the transition. The Program Announcement (PA-16-077 as of May 2016) states that "The application for the R00 phase of the award must be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization." However, as always you have to BUDGET TIME well in advance, because since you're not at your new institution yet, everything will take twice as long.

This is what you R00 application should include, with added suggestions from what I just went through:

A new face page signed by the R00 phase institutional representative. This is pretty straightforward and Sponsored Programs at your new institution will do, but remember there may be hoops, multiple signatures may need to be collected, last minute questions that send you scrambling from answers, and NIH regulations require everyone on the grant to be trained on Financial Conflict of Interest and to sign disclaimers (which you may have done at your current institution, but need to redo for the new one, so say goodbye to an afternoon).

A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase). This is fine, just update.

Detailed budget pages for a non-modular budget. This is uncharted territory for non-budget savvy and it took me almost 2 full days with the help of a very responsive administrator, despite the fact that I had templates to follow. The K99 budget is very easy, but the R00 includes salaries, equipment, supplies, animals and other odd and ends like publications and travel, and you need to think about it to justify every single dime. You need quotes for equipment, updated amounts for salaries and fringe, estimates for animal costs and supplies. It's one thing if you're there and you can sit next to someone and go through the numbers with them, but if you're not, it can take a while. Also see this post for salary percentage negotiations.

Biographical sketches. Just update, but remember that if you already have personnel listed on the grant, they'll need biosketches too.

Other support. Just update.

A new Resources page. Ha! This was a piece of cake at your postdoc institution, where you just copied your boss' R01. At the new place you have to figure out what's in the cores, where exactly is the equipment you know is there and what kind of access you are going to have. Your facility needs may not be same as those of other people, so you either get multiple lists or you have to rely on multiple people to give you tidbits of information. And again, you are not there. I was lucky as everyone was extremely helpful, but I had friends who had to fly back to the new place and gather everything that they needed in person.

A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase. If you did a Year 1 report, it's the same format as described in the Program Announcement, but just a final report. You better have done some of the work, because I heard the NIH can give you grief if you have not actually worked on the project.

A final evaluation statement by the K99 phase mentor. Nice long letter detailing how wonderful you are and all the mentoring you received during the mentoring phase. Basically take the mentoring plan and rewrite it in the past tense.

An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages). I heard conflicting reports on this: some people submitted a slightly modified version of the K99 proposal continuing on that work and some had to do a major overhaul which is equivalent to writing a new grant. I did a pretty substantial rewrite adding new experiments to follow up the old Specific Aims, so it was time consuming. In general I find short formats much more difficult to write and 5 pages for Significance, Innovation, and Approach including Preliminary Data is not much.

A letter from the R00 Department or Division Chairman describing the R00 institution's commitment to the candidate and plans for his/her career development. This is similar to the institutional commitment letter for the K99 portion, but it should relate to your new institution. It should also detail the search process to get to you as the best candidate for the position, describe your hiring package and the faculty development programs at the new place. Chairs are busy...letters take time.

A new checklist. Sponsored Programs will do when they assemble the application.

IACUC or IRB approval. If you work with vertebrates or humans they will ask you for your protocol approval. If you are like most people you will not have started these in advance, but beware since they may hold up your grant until these are approved, which could mean another couple of months.

A friend told me it took much longer that she had anticipated and she was absolutely right. You are getting ready to leave and you have a million and a half things to do in the lab, in addition to dealing with moving your personal life somewhere else. It is true that the R00 is reviewed internally and it's not going to a study section, BUT it's still a major NIH grant and you are asking the government for $750,000, so it should be done well. Also remember a little known secret, the unspent part of your K99 will go away if you transition earlier than the 2 years, so be warned.

I'll follow up on what happens with my application. Remember to visit the Writing Grants page for more posts and links.
Note: around 5 weeks after submission my R00 was approved with flying colors....and no funding was cut because of sequestration!

55 comments:

I am scrambling to put together my R00 application and found this while seeking help from the interwebs. This is by far the most useful thing I have found. Thank you! And congratulations on starting your own lab!

Dear New PI,I am going to be submitting my R00 soon, and I am grateful for your informative blog.For the R00 budget, do you really need vendor quotes for all equipment, or can you itemize and put the price listed by the company (Fisher, VWR, etc) website? And once you submit, can you purchase equipment other than what you listed on your R00, or is that more flexible?

Hey there, I got quotes because I was buying a microscope and I needed a special item description and price. Anything below $5,000 should not go in the equipment budget and you can just add a few things above. I ended up demoing an array of scopes and I ended up going with another vendor from the one quotes in the R00. It wasn't a problem and I used the amount as a guideline of how much I was supposed to spend. I don't know what happens if you spend more than the amount quoted, because I stayed within that range.One thing I discovered, is that the process of buying equipment through Federal funding is actually very complex and can require competitive bidding run through your procurement department. Ask in your institution how it works, because it was a surprise to me. It ended up being very helpful because we had issues with the order and procurement worked with me to get everything rectified to my satisfaction.....

Thank you for your help! I have two follow-up questions.Does this mean that I need to get the university to approve of each item in the equipment list and its cost before I can submit the grant to the NIH (so the vendor quotes are really more for the grants office approval prior to submission)?Secondly, would the NIH disapprove if I request purchasing basic lab equipment (like freezers) from the R00, since these are such basic necessities that the university should be giving you enough money from startup? Or do they not care as long as it is justified as necessary?

I stated that I that I was going to use equipment to buy a fridge, -20, and -80, as well as incubators on my R00 budget. My situation may have been a little different due to difficulties getting my offer and hiring university approved for the R00, but it all went through easily.

1) For that you need to talk with your grants specialist at your university and figure out how to do things, some want quotes and some do not, mine want quotes and everything has to be approved by the university before it is submitted.2) As for basic lab equipment I have no idea. I found out that ordering equipment through federal funds is a huge pain and that some people do not even bother putting equipment on NIH grants because it takes such a long time. You need to identify the exact specifications for the equipment and then procurement has to do an open bid for quotes where the vendors compete and adjudicate the contract. Unless you can justify a sole vendor in a very persuasive way. You should really discuss with your procurement office how they do things where you are. I was completely blindsided when I went to order my scope and everything I had done was wrong....I then discovered that procurement can be a huge asset in helping with your purchases, so you want to talk to them early.

I was once told that everything you buy on NIH funds belong to you and that what you buy on start-up belongs to the university, so if you buy equipment and decide to leave, you can take it with you, BUT I am not entirely sure that this is true, because I've seen some conflicting information about this. Also, I have heard from several friends that if you move you can always "buy" all your stuff off your institution at a discounted price.

Finally, ask around if someone is shutting down labs or has unused equipment, I picked up my freezer and fridge from people, plus a couple of microscopes and random little things. AND ask if you can buy freezers from Sears or restaurant supply stores....a delicase from VWR costs 10K and a similar item is 2K from webstaurantstore.com.

Dear new PI,Many thanks for your post - this is great information -- a real gem, as there is nothing else like it on the web! I was wondering for the R00 grant, do you still submit the PHS 398 Career development Supplemental Form, that includes the Training documents for career development and responsible conduct of reattach?

I don't think you do. The required documents are only the ones listed in the program announcement. You need a new letter from your department chair which describes your recruitment and institutional commitment, but you should be clear of the "career development" portion of the grant. Since this is a rolling submission you can always double check with your program officer. They'll ask you if they need anything else as they move forward with the internal review.

Dear new PI,This blog is super helpful. I am also working on my R00 grant. I know the proposal goes through internal review, but are there actually cases where the applicant secured a tenure-track position in the US and still got denied the R00 grant? How much do they scrutinize your scientific proposal and how much do they expect you to have actually worked on the project? With only 5 pages, as you said, it is difficult to include enough detail on everything, like caveats/alternative approaches, significance, etc.

Thanks, glad this is helpful. I have heard of at least one instance where someone had done nothing on the K99 project, resubmitted the whole thing pretty much untouched and did not get the R00. I completed a lot of the aims and didn't do some other things because they got published by other people, so I wrote a completely new proposal stemming from the work of the K99 portion. I think that as long as the proposal is reasonable and you have done some work, it shouldn't be a problem. If you have not done anything then it's another issue and you should diplomatically find a way to talk to your program officer and see what he/she would advise....but you should have some plausible excuse on why nothing was done, such as reagents failed, your mouse line died or your original hypothesis is wrong and have come up with an alternative hypothesis which will be way cooler. The program people know what is going on and have a huge experience in seeing a whole bunch of proposals and knowing what is cutting edge or not. You still have to make your R00 exciting for them.

Dear new PI,This is an awesome blog - thanks! I was wondering after you submitted your R00 what the process was like. Did you receive any additional input/communications or did you only get a response after 5 weeks like you mention?

Hi, no other feedback, just submitted everything and had my response after 5 weeks. The NIH recommends at least 2 months of lead time, so make sure you talk to your program officer a few months before because I cannot guarantee that it'll be 5 weeks. I communicated with my PO often before I submitted. Also remember that if you have animals and need IACUC approval, even if your funding gets approved they may not release the grant until you have formal approval of your protocols, so you'll have that to do while you wait for the grant to be approved :)

Thank you for this helpful blog! I have a question about the timeline. My new institution hasn't submitted my R00 application yet, but I want to start my new faculty position at the end of the month, at which point my K99 will be terminated. The NIH instructions say that funding should be continuous, but I have two problems: 1) if I terminate the K99 to start my faculty position early, and the R00 is still in review during that time, funding won't be continuous, and 2) my animal protocol can be approved only after I do several hands-on training which I can do only after I move there. So even for just point #2, the funding wouldn't be continuous. How are these above issues handled?

Sorry, I just saw this because it ended up in my spam. Did you figure it out? My understanding is that there can be a break of up to 1 year between then K99 and R00 part, but my suggestion would be to speak with your program officer. I assume that as long as your R00 is under review while your K99 is terminated you are fine. Your R00 will be activated whenever it get approved and they put together the Notice of Award and in the meantime you can get your protocol in order. The only way to know for sure is to talk to the NIH though. Let us know what happened, it may be helpful to others.

Dear New PI,Thanks so much for this blog! I have a couple of question that was hoping you may help me with:-- For the R00 duration, can the funds be reallocated, say from salaries to supplies or travel etc, or this needs to be approved by the grants manager?-- Do leftover funds automatically carry over-- Are you applying for other grants? What is the minimum effort required to keep the R00 active (50%?). Super thanks!

Hi, 1) you put together your budget for the R00 when you apply, but then I think there is a bit of flexibility on where the money is going. My understanding is that the amount for salaries and supplies are separate, but within the salaries I know you can change percentages up to 25% effort in case people change or you need to move salaries around. I don't think travel, etc are fixed and separate from supplies and your grants office should be able to move them around. If your changes are SUBSTANTIAL, more than 25% effort or non-budgeted equipment, I think you need approval of your grants manager.2) For the R00, unobligated funds of less than 25% of your annual budget carry over automatically, but if you have more than 25% left over you need to explain why you did not spend the money and get approval. For the K99, anything you didn't spend is lost and will be used to offset the 2nd year of the R00, so that the amount you will get from the NIH will be your budget minus whatever is left from the K99.3) The minimum effort to keep the R00 active is 75% and you have to maintain that. Your salary can be less if your department agrees to cost-share the difference, e.g. your grant pays 40% of your salary and your department pays the remaining 35%. Then you have to figure out what to do with the 25% effort which is left. You may need to keep some for teaching (10-15%) but you can put the rest on other grants. A lot of young investigator grants do not provide salary support, so you can keep your effort small 5%, but you need to make sure you do not overextend yourself. Your departmental grants manager should be able to help. I'm applying to lots of grants and when I apply for an R01 that will also probably be at 5% or so for year one and then increase when the R00 ends.

Hi New PI,I am a little confused about the carryover from K99 to R00: "the amount you will get from the NIH will be your budget minus whatever is left from the K99". Do you actually mean "the amount you will get from the NIH will be your budget PLUS whatever is left from the K99"? Thank you for this super great post!

Let's say you have 60K left in your K99 which were already awarded to your K99 institution, your R00 institution will have to obtain that money from them and the NIH will send you the remaining 190K. So the NIH itself sends your R00 institution less money with the assumption that they will have recouped the rest of the money from the K99 university. Prepare for your grants people to be utterly confused from the Notice of Award if they have never seen one before.

Dear New PI,Thanks so much for this helpful post! There is a reasonable amount of information on applying for the K99, but not so much for the R00 portion. I have a couple of questions: 1) I know that an updated specific aims page and 5 page research plan has to be submitted. For my K99 application, I had 1 aim for my K99 portion and 3 aims for my R00 portion. For the R00 application aims, are the K99 aims supposed to be removed? Or are they left untouched, and the R00 portion is updated as needed? I've seen abstracts on NIH reporter where the K99 abstract and R00 abstract are identical, and have lines like "during the K99 period, the applicant will... "

2) From my first submission to my K99 award was just over a year, and was awarded in early July. While waiting for the award, I received a tenure track job offer I am very happy with. I am under the old PA (PA11-197). Will there be any issue if I bring up this job offer, and transitioning ~2 months early with my PO? (The issue being that my award just started and I'm already talking about a job offer).

Hi, thanks, this post has originated a lot of great questions.This is what I think, but you should definitely check with your PO:1) you can update the R00 application as you wish. As I mentioned, I had done a good part of it, so I almost wrote a new grant. If you already have three R00 aims, you could just use those and say that the K99 portion is complete, if it is....or update as necessary.2) I think that having a job offer at the time of award is actually a pretty common thing. Your PO may ask you to complete the first K99 year and so you may have to delay your start-date for your new job. Universities are usually very happy to comply because they get A LOT of money from the R00. Your PO should be able to counsel you as far as the requirements of your IC. Also your PO can be your ally in going over the offer and discussing terms so you should really discuss the offer with her/him before you negotiate. There is no tactic more powerful than "The NIH says that you need to do this..." In general I recommend to complete the full year plus 2-3 months of the K99. If you tack along a few extra months you'll receive your supply budget for Year 2 which will be a decent amount of money you can use for your new lab. Whatever K99 portion is not spent is lost (actually will come back in Year 2 of your R00 to offset what the NIH owes you), and you could definitely use those 20K or so that come with your supply budget to start buying supplies for the new lab.Hope this helps!Congrats on the job!!

Thanks so much for your quick response and great advice! I only applied for 1 year of funding for the K99 portion, so I won't be able to use the 1 year + few months strategy. I will definitely follow up with my PO. Thanks again, I'm now reading through all of your other helpful posts on grant writing/budgeting etc.

You budget the K99 for salary and supplies or anything else you need to add then you budget the remaining 3 years at $250,000 each without detail. Once you do the R00 application that's when you need to do a more detailed budget for the independent part. Your grants administrator should be able to help you with the budget for the K99/R00.

Dear new PI, I have one simple question here, I am wondering if I can apply the k99/R00 grant in Feb 2015? Since I will start the 5th year of post-doc on March 7 of 2015. I can submit the initial application but not for resubmission, right?

Dear New PI,Thank you for this fantastic post. I am starting my R00 writing two months early because of you.

I am currently trying to organize information about the letter written by my new Department Chair. I have found references to the Institutional Commitment and Environment piece, but no explicit description of what she should say about the department's search, my hiring package, and development support. I would be grateful if you (or someone else!) could direct me to the NIH language describing all of this.

Dear New PI,Thanks for the post. I am a bit confused about the progress report format. I only have 1 year on the K99, so I haven't written the progress report before. I see on the program announcement that it says: "When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed."But the PHS2590 has a lot of redundant info with the R00 application (face page, etc). Also the additional instructions seem to be using eRA commons, but I am submitting a paper application directly to the GMS. Thanks for your help!

Hey there, short answer is I'm not sure. Between the time I did my progress report for the K99 and now the RPPR came online, so now my R00 report is an RPPR. See post on the RPPRhttp://thenewpi.blogspot.com/2014/02/i-survived-rppri-think.html

You should ask your institute if you have to do an RPPR online for your report or not. At the end you get a PDF which you can include in your paper application.IF you just have to do a old fashioned report included in the R00 application the format used to be 3 pages (excluding figures) where you listed: A. Specific Aims: few sentence on whether there were any changes from the original specific aims. B. Studies and results: summary of results. C. Significance: why what you found is important. D. Plans: I will be an assistant professor and transition to the R00. E. Publications. F. Project generated resources: mice, viruses, constructs. I will be friendly and share. G. Research Development: What I have learned, conferences I have attended, seminars I have given, responsible conduct in research statements. H. Other activities such as teaching or career development courses or seminars attended. I. Activities planned for the new yearHope this helps.

Hi, This is a huge service to the rest of us looking to transition. Thanks so much.

My question relates to the budget when one transitions from K99 to R00 a quarter of the way through the first year. Since the money disappears if not used can one use that money for supplies and equipment and simply move that to the new institution? My simplified budget for the K99 generally specifies $60K for salary and 30K for supplies. Since I will not be taking the salary component for the rest of the year it would be great if that could be reallocated to be used for necessary supplies and small pieces of equipment. This would really maximize how my money is spent. Any thoughts on whether this is an acceptable thing to do?

Unfortunately, the money for salary will mostly will be lost to you. My understanding is that the salary vs supply border is mostly set, but that you can shift effort by up to 25% without requesting NIH approval. Anything more, you have to request approval from your PO. I know this to be valid for R01 and I'm not sure whether this applies to R00. As far as I know everyone who has transitioned before ending Year 2, has lost part of the salary.That money does not disappear, but it is actually sent from your postdoc institution to your faculty institution, where it will be used to offset payment for Year 2 of the R00. E.g. you have $60K left for your salary on K99, they will go to the new university and the NIH will only give you $190K for Year 2 of the R00...because apparently the money cannot be returned to them once it was disbursed.

Is the R00 considered a new award or a continuation award? I ask b/c I am waiting for money to arrive at the R00 institution. I can spend pre-award money only 90-days prior to award date (for a new award) - and there is no way to figure out the award date, right? A continuation will permit use of the money now.

I have no idea about this one. The number of the grant stays the same and the initial code just changes from K99 to R00. This is something you could ask the Grants Management person on your eRACommons. They phone number and email should be at the bottom below the Program Officer. Let us know what you find out.

My question is about tenure-track versus non-tenure track positions. Many medical centers offer non-tenure track positions. Medical centers are a good environment for research which poses a dilemma for my faculty search. The grant states "tenure-track (or equivalent)" positions. Do you have any experience with this issue? Is it expected that the position is tenured for the activation of the R00?

I think you need to talk to your Program Officer regarding this. If the medical center position is an independent junior faculty position (e.g. instructor, investigator), it should be equivalent to a tenure-track position. Tenure-track can mean a lot of different things with tracks going from 6 to 10 years, to almost never. So, as long as it comes with an independent position, start-up money and space, it should be equivalent. You can actually send your offer letter to your PO and have them evaluate it. It will help with negotiations.

Hi-As I'm submitting R00 right now, I'm a little confused by the 5-page limitation for research strategy. Does that include specific aims? What about submitting references and enrollment tables (and appendix materials)? I don't see those as required submission items on the directions, but I would think those are important!

It's exactly like any other NIH grant, so the 5-page limit is just for the research strategy. The Specific Aim page is separate and the references go on a separate file. I assume you'll have the enrollment tables in your human subjects section.

I just want to say thank you for maintaining this great blog. I too am applying for the R00 transition and this blog is extremely helpful as it was during the K99 writing. I am impressed that you even take time out of your busy schedule to respond to questions. The blog in general is such a great resource for Postdocs and new PIs. Thank you so much for your efforts!

Hello! Thanks so much for having this blog! I am preparing my R00 as well, though I am confused with where is the 5-page limit of the research strategy coming from. I couldn't find it on NIDDK website...

Hi New PI,I really appreciate this blog. Do you think that I can change or add a co-mentor for newly approved k99 application? The professor, who agreed to train me, wants to have a official track record of training k99 awardee and I also have better training opportunity if the professor is officially appointed as a co-mentor. Thanks.

Hi, thank you for your support! Congrats on the K99. As far as adding a mentor, I'm not sure, because the mentoring team was reviewed with the grant, but I would ask the PO. They will be able to tell you and they will need to be the ones approving the change. I don't see why this would not be possible as having more mentors is always better.

Although I got a favorable score of my K99, I need to wait a couple of months for the payline decision. Meanwhile, I am negotiating an offer from my current institution. Although I know that NIH prefers the researcher to move to a different institution in the R00 phase, due to many reasons, I prefer to stay at my current institution. Can I still contact PO to review my potential offer before I accept it? May you suggest some potential issues that I should be aware of?

Hey there, thank you for following.The program announcement just says "A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase". I think it helps making it similar to the RPPR because it's easier for the PO to follow. Mine was around 5 pages including a report on professional development. Best of luck!

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About Me

I'm a biomedical research scientist venturing into starting an independent research lab in academia. The goal of this blog is to share my experience and new/interesting ideas about management and grant writing with friends and colleagues. All ideas expressed in this blog are my own.